APPLICATION
ANDA079070
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-10
LATEST ACTION
2024-01-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PERINDOPRIL ERBUMINEPrescription
PERINDOPRIL ERBUMINE 8MG · TABLET · ORAL
PERINDOPRIL ERBUMINEPrescription
PERINDOPRIL ERBUMINE 2MG · TABLET · ORAL
PERINDOPRIL ERBUMINEPrescription
PERINDOPRIL ERBUMINE 4MG · TABLET · ORAL
Approval history
2024-01-10Labeling · Supplement 7 · standardAP
2015-05-20Labeling · Supplement 6 · standardAP
2015-05-20Labeling · Supplement 4 · standardAP
2011-10-17Labeling · Supplement 3AP
2011-07-21Labeling · Supplement 2AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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